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Enrolling by invitation NCT07167836

Automated Clinical Pathway for Inflammatory Bowel Disease Care

No phase Interventional Inflammatory Bowel Disease Inflammatory Bowel Disease (IBD)

For patients and families

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electronic medical record-based care pathway.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Disease, Inflammatory Bowel Disease (IBD). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of an Automated Clinical Pathway Utilizing Tailored Risk Stratification on Rates of Overdue Follow up and Outcomes in Patients With Inflammatory Bowel Disease

Overview

Pragmatic randomized controlled trial to evaluate the effect of an electronic medical record-based tool on improving on-time follow up and its effects on inflammatory bowel disease outcomes

Interventions

  • Other Electronic medical record-based care pathway
    Participants will undergo initial automated risk stratification to direct tailored follow-up intervals. If exceeding the maximum time interval, participants in the intervention arm will be contacted by scheduling personnel using a standardized protocol to schedule a follow-up visit. In contrast, patients in the control arm who are overdue will not be made known to any staff and will not be proactively contacted, instead continuing to be managed according to standard of care. To maximize generali

Primary outcome measures

  • Proportion of days overdue for completion of clinical follow up [Time frame: 12 months]
Secondary outcome measures (2)
  • Composite clinical outcome: acute care utilization, steroid use, or inflammatory bowel disease-related surgery [Time frame: 12 months]
  • Proportion of patients with bowel-specific inflammatory assessment [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Alive patients with 2 or more visits to the UT Southwestern adult digestive disease clinic within 3 years of the date of trial commencement including at least one visit within 2 years, and
  • An active inflammatory bowel disease-specific medication, and
  • At least one of the following:
  • Inflammatory bowel disease on the active problem list
  • An inflammatory bowel disease invoice diagnosis at least twice in the 3 years prior to trial commencement
  • An inflammatory bowel disease encounter diagnosis at least twice in the 3 years prior to trial commencement

Exclusion criteria

Patients not meeting inclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • UT Southwestern — Dallas

Identifiers

NCT: NCT07167836 · STU-2024-1013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗